RecruitingNot ApplicableNCT04764357

Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors

COOLCAP Pilot Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors


Sponsor

St. Jude Children's Research Hospital

Enrollment

40 participants

Start Date

Jun 4, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if the Paxman scalp cooling device can prevent hair loss in pediatric patients receiving chemotherapy for non-cancerous conditions or solid tumors. Primary Objective * To assess the safety and feasibility of the use of a scalp cooling device in pediatric and young adult patients receiving chemotherapy for non-malignant conditions and solid tumors. Exploratory Objectives * To assess the incidence and intensity of chemotherapy induced hair loss in patients receiving chemotherapy for non-malignant conditions and solid tumors who have used a scalp cooling device.


Eligibility

Min Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a scalp cooling (cold cap) device can help prevent or reduce chemotherapy-induced hair loss in pediatric patients (age 7 and up) who are receiving chemotherapy for solid tumors or non-malignant conditions like sickle cell disease or aplastic anemia. Scalp cooling works by reducing blood flow to hair follicles during chemotherapy infusion, making them less exposed to the toxic drugs. It is already used in some adult cancer patients. Hair loss from chemotherapy can be deeply distressing, especially for young patients and their families. This study will help determine whether cold caps are safe and effective for this younger population, and for patients receiving chemotherapy for non-cancer conditions. You may be eligible if... - You are at least 7 years old - You are receiving chemotherapy likely to cause alopecia (such as cyclophosphamide, doxorubicin, paclitaxel, etoposide, or similar drugs) - You have been diagnosed with a solid tumor (non-brain) or a non-malignant condition (e.g., sickle cell disease or aplastic anemia) - Your head circumference is 50 cm or greater You may NOT be eligible if... - You are receiving chemotherapy for a blood cancer (hematologic malignancy) - You have a brain tumor, scalp tumor, or high risk of brain/scalp metastases - You have cold agglutinin disease or cold urticaria - You have an active scalp infection at enrollment - You have previously had a bad reaction to the Paxman scalp cooling device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPaxman Scalp Cooling System

Scalp cooling will begin at least 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for at least 120-180 minutes after discontinuing the infusion. Scalp cooling will occur with each dose of chemotherapy.

OTHERAlopecia Assessments

Photographs will be taken prior to the use of the scalp cooling system and once at the end of the study. Patients with solid tumors will have additional photographs taken after every 2 cycles of chemotherapy.

OTHERPatient Reported Outcomes Questionnaires

* Selected questions from NCI PRO-CTCAE™, Chemotherapy-Induced Alopecia Distress Scale (CADS), and PediQUEST Memorial Symptom Assessment Scale, at the following time points: baseline, after every 2 cycles of chemotherapy, 4 week follow up and end of study. * Tolerability Questionnaire each time the cooling cap is used and at the end of study


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT04764357


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